Antibiotic recalled on potentially "potentially deadly" contamination, warns the FDA
The recalled atovaquone can cause dangerous infections, especially in immunocompromised patients.
Becoming sick is never fun, especially if it requires a trip to urgent care or a free time of work. And if your doctor diagnoses you with a bacterial infection, they will probably prescribe a antibiotic To get it out of your system over a few days or weeks. But now, the Food and Drug Administration of the United States (FDA) issues a warning concerning a specific antibiotic - Atovaquone - which can have the opposite effect, potentially leading to "potentially fatal infections".
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According to a March 29 Press release , Avkare, LLC voluntarily remembers a batch of oral suspension of Atovaquone, USP 750mg / 5 ml which was distributed at consumers / user. The drug is prescribed "for the prevention and treatment of pneumocystis jiroveci pneumonia (PCP)", which is an infection caused by THE Jirovecii pneumocystis mushroom ,, According to centers for Disease Control and Prevention (CDC). The drug is indicated for use in adults and children aged 13 and over who cannot tolerate other treatments, namely the trimethoprime-sulfamethoxazole, the FDA release states. AE0FCC31AE342FD3A1346EBB1F342FCB
This specific Atovaquone oral suspension batch, USP (Lot AW0221A) number is drawn due to the "potential Bacillus cereus Contamination, "which was discovered when the product has undergone stability tests in a third -party laboratory, the FDA declares. According to the Cleveland Clinic, Bacillus cereus ( B. Cereus ) is a bacteria forming spores that produces a harmful toxin that makes you sick. It can cause food poisoning as well as non -intestinal diseases.
"In the most risky population, the immunocompromised population, there is a reasonable probability that microbial contamination of the oral suspension of the Atovaquone can lead to disseminated infections and endangering life such as endocarditis and infections to infections Necrotic soft fabrics, "said the press release.
As the Mayo clinic indicates, endocarditis is an inflammation of the rooms and the valves of the heart, while necrotizing infections of soft tissue Turn off patches of fabric, by Johns Hopkins Medicine.
Although these conditions are serious, from the release of March 29, Avkare had not received any report of adverse events related to the recall. However, health officials are asking for consumers to contact their doctor or health care provider if medication problems arise.
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Recalled an oral suspension at the Atovaquone, USP products were packed in boxes and distributed between March 18 and March 21 nationally for wholesalers. The affected products can be identified by the National Drug Code (NDC) 50268-086-12, which is listed in red on the packaging, as well as by the universal product code (UPC), 5026808612, which is printed under the code- bars.
Avkare informs distributors and wholesale customers of the recall by shipments and emails, also organizing a return of the drug. Wholesalers are invited to "examine their inventory" and cease to provide all the prizes recalled. Consumers who have this product at home should stop using it immediately, according to the FDA instructions. The oral suspension of the Atovaquone, USP products can be returned to the place of purchase or thrown.
The FDA also asks you that you report unwanted reactions or quality problems to its MEDWATCH unwanted event reports program online ,, by email , or by fax.
For specific recall questions, consumers can contact Avkare by phone at 1-855-361-3993 or by e-mail [Protected by e-mail] , Monday to Friday, between 9 a.m. and 5 p.m. Standard time in the East (East).